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ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy (ADVANCE_D)

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ClinicalTrials.gov Identifier: NCT00147277
Recruitment Status : Completed
First Posted : September 7, 2005
Results First Posted : May 12, 2009
Last Update Posted : August 13, 2015
Sponsor:
Information provided by:
Medtronic Bakken Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Tachycardia, Ventricular
Ventricular Fibrillation
Intervention Device: Implantable Cardiac Defibrillator
Enrollment 925
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 8 Pulses Anti-Tachycardia Pacing (ATP) 15 Pulses Anti-Tachycardia Pacing (ATP)
Hide Arm/Group Description 8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) 15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
Period Title: Overall Study
Started 475 450
Completed 475 450
Not Completed 0 0
Arm/Group Title 8 Pulses Anti-Tachycardia Pacing (ATP) 15 Pulses Anti-Tachycardia Pacing (ATP) Total
Hide Arm/Group Description 8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) 15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) Total of all reporting groups
Overall Number of Baseline Participants 475 450 925
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 475 participants 450 participants 925 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
214
  45.1%
203
  45.1%
417
  45.1%
>=65 years
261
  54.9%
247
  54.9%
508
  54.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 475 participants 450 participants 925 participants
64  (10.9) 63.4  (12.2) 63.7  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 475 participants 450 participants 925 participants
Female
66
  13.9%
48
  10.7%
114
  12.3%
Male
409
  86.1%
402
  89.3%
811
  87.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 475 participants 450 participants 925 participants
Italy 180 169 349
Germany 109 106 215
France 84 77 161
Spain 76 75 151
Portugal 7 8 15
Belgium 8 7 15
Israel 9 6 15
United Kingdom 2 2 4
1.Primary Outcome
Title Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)
Hide Description Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
934 patients were created in the electronic data capture system, only 925 patients were enrolled in the study: 4 patients in the 8 pulses arm and 5 patients in the 15 pulses arm were created by mistake and excluded from analysis. The analysis were performed with the Intention To Treat (ITT) method.
Arm/Group Title 8 Pulses Anti-Tachycardia Pacing (ATP) 15 Pulses Anti-Tachycardia Pacing (ATP)
Hide Arm/Group Description:
8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
Overall Number of Participants Analyzed 475 450
Measure Type: Number
Unit of Measure: Percentage of FVT episodes terminated
64.9 69.7
2.Secondary Outcome
Title Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention
Hide Description [Not Specified]
Time Frame one year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms
Hide Description [Not Specified]
Time Frame one year
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Percent Reduction in Shocks Delivered Per Patient for Treating FVT
Hide Description [Not Specified]
Time Frame one year
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Compare Likelihood of Syncopal Events Associated With FVT
Hide Description [Not Specified]
Time Frame one year
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Evaluate Different Possible Predictors of ATP Success
Hide Description [Not Specified]
Time Frame one year
Outcome Measure Data Not Reported
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Laura Manotta
Organization: Medtronic Italia S.p.A.
Phone: 003902241371
ClinicalTrials.gov Identifier: NCT00147277     History of Changes
Other Study ID Numbers: 900AD
First Submitted: September 6, 2005
First Posted: September 7, 2005
Results First Submitted: November 20, 2008
Results First Posted: May 12, 2009
Last Update Posted: August 13, 2015